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1、 Table_yemei1 观点聚焦 Investment Focus Table_yejiao1 本研究报告由海通国际分销，海通国际是由海通国际研究有限公司，海通证券印度私人有限公司，海通国际株式会社和海通国际证券集团其他各成员单位的证券研究团队所组成的全球品牌，海通国际证券集团各成员分别在其许可的司法管辖区内从事证券活动。关于海通国际的分析师证明，重要披露声明和免责声明，请参阅附录。(Please see appendix for English translation of the disclaimer)研究报告 Research Report 9 Jun 2025 信达生物信达生物 I

2、nnovent Biologics(1801 HK)2025 ASCO 数据超预期，创新潜力不断兑现 2025 ASCO Data Beats Expectations,Validating Sustained Innovation Execution Table_Info 维持优于大市维持优于大市Maintain OUTPERFORM 评级 优于大市 OUTPERFORM 现价 HK$73.15 目标价 HK$90.10 HTI ESG 3.6-1.4-3.5 E-S-G:0-5,(Please refer to the Appendix for ESG comments)市值 HK$120

3、.81bn/US$15.40bn 日交易额(3 个月均值)US$146.21mn 发行股票数目 1,652mn 自由流通股(%)93%1 年股价最高最低值 HK$74.25-HK$30.00 注：现价 HK$73.15 为 2025 年 06 月 06 日收盘价 资料来源：Factset 1mth 3mth 12mth 绝对值 33.2%82.2%97.2%绝对值（美元）31.6%80.5%96.3%相对 MSCI China 31.2%86.9%74.4%Table_Profit Rmb mn Dec-24A Dec-25E Dec-26E Dec-27E Revenue 9,422 11,

4、863 14,342 18,172 Revenue(+/-)52%26%21%27%Net profit-206 384 849 1,765 Net profit(+/-)n.m.-286%121%108%Diluted EPS(Rmb)-0.13 0.24 0.52 1.08 GPM 84.0%83.7%84.7%88.0%ROE-1.6%2.8%5.9%10.9%P/E n.m.284 128 62 资料来源：公司信息,HTI (Please see APPENDIX 1 for English summary)事件事件 信达生物多项研究入选信达生物多项研究入选 ASCO 口头报告，彰显公

5、司肿瘤创新药物研口头报告，彰显公司肿瘤创新药物研发的强大实力。发的强大实力。公司在 2025 年美国临床肿瘤学会（ASCO）年会上公布肿瘤创新管线系列临床数据，共有8项口头报告，约占大会口头报告总数的 2%，涵盖 IBI363（PD-1/IL-2-bias）和 IBI343（CLDN18.2 ADC）等药物多项研究成果。其中重点关注点在于IBI363 相关研究包括在免疫治疗后晚期肢端及黏膜黑色素瘤、晚期结直肠癌、晚期非小细胞肺癌患者中的疗效与安全性研究；IBI343的 I 期剂量扩展队列研究聚焦 Claudin18.2 在胰腺导管腺癌中的表达与疗效。点评点评 我们认为我们认为 IBI363 在

6、在 IO 经治非小细胞肺癌、结直肠癌数据持续亮经治非小细胞肺癌、结直肠癌数据持续亮眼，再次验证了该分子成为下一代眼，再次验证了该分子成为下一代 IO 疗法基石药物的潜力。疗法基石药物的潜力。IBI363 在非小细胞肺癌、结直肠癌、黑色素瘤三项免疫耐药及冷肿瘤中，均以口头报告形式报道了令人鼓舞的 I/II 期临床数据，从肿瘤响应到长期生存获益，全面地展现了IBI363在各适应症的亮眼研究结果。1）IBI363 单药治疗单药治疗 IO 耐药的晚期非小细胞肺癌耐药的晚期非小细胞肺癌 mPFS 数据超预数据超预期期：IBI363 单 药 用 于 晚 期 NSCLC 受 试 者 的 更 新 数 据（NC

7、T05460767）。截止随访时间 2025 年 4 月 7 日，共 136 例NSCLC 受试者接受了 IBI363 单药治疗（2g/kg QW4mg/kg Q3W），其中包括 67 例鳞状非小细胞癌和 58 例 EGFR 野生型腺癌。67 例鳞状非小细胞肺癌均无已知的 EGFR 突变，其中 28 例接受了1 mg/kg Q2W 或 1.5 mg/kg Q3W IBI363 治疗，31 例接受了 3 mg/kg Q3W IBI363 治疗。两组受试者既往系统性治疗线数2 线的比例为64.3%vs 67.7%，既往抗 PD-1/PD-L1 治疗的比例为 100%vs 96.8%，PD-L1 T

8、PS1%的比例为 35.7%vs 41.9%。相较于 1/1.5 mg/kg 剂量组，3 mg/kg Q3W 剂量组观察到更突出的确认的 ORR：cORR 36.7%，DCR 90%，mPFS 9.3 个月（mPFS 比肩标准疗法多西他赛 OS 数据，超越 PD-L1+CTLA-4 等 IO 组合疗法mPFS），mOS 尚未成熟（中位随访时间 11.3 个月），我们认为未来随着随访时间延长，mOS 将有可能大幅度优于现有疗法。此外，3mg 剂量组的 mDoR 也比较长，随访 9.7 个月后事件数达36.4%，意味着在响应人群中药物持续有效时间较长。安全性整体可控，Gr3 TRAEs 43.9%

9、，最常见的 Gr3 TRAEs 是关节痛和皮疹，7.0%的受试者发生了导致永久停药的TRAE，TRAEs导致的死亡发生率 0%；Table_Author 孟科含孟科含 Kehan Meng 宁嘉骏宁嘉骏 Jiajun Ning,PhD 60100140180220Price ReturnMSCI ChinaJun-24Oct-24Feb-25Volume 9 Jun 2025 2 Table_header1 信达生物(1801 HK)维持优于大市维持优于大市 2）IBI363 单药治疗冷肿瘤单药治疗冷肿瘤 3L+结直肠癌结直肠癌 mOS 数据相比现有疗法延长约数据相比现有疗法延长约 6 个月：

10、个月：针对3L+治疗失败的 MSS 型结直肠癌患者，单药治疗组中，63 名患者（4L+63.2%，MSS占比 86.8%）。ORR 为 12.7%，mDoR 为 7.5 个月，mOS 为 16.1 个月（对比现有疗法 mOS 9-10 个月有显著延长），其中肝转（14.4 个月）和无肝转组（17 个月）OS 获益都优异，显示了免疫治疗持续的拖尾效应所带来的长期生存获益，有望逆转 IO 疗法在免疫冷肿瘤的无效表现。联合贝伐治疗组 ORR 23.5%，mDoR 和 mOS均未成熟，但亚组分析显示 3mg 高剂量组的 ORR，PFS 表现优异，令我们期待高剂量组更长随访时间后的生存获益数据。3）IO

11、 经治的黑色素瘤疗效出色：经治的黑色素瘤疗效出色：两项 I、II 期临床研究（NCT05460767，NCT06081920），截至 2025 年 4 月 7 日，31 例不可切除局部晚期或转移性肢端型及黏膜型黑色素瘤患者，接受 1 mg/kg Q2W 剂量治疗，所有患者均为免疫治疗耐药，其中 20 例（64.5%）既往接受过 2 线或以上的抗肿瘤治疗。患者 cORR 23.3%（对比化疗等 SOC 7%-11%），PFS 5.7 个月（对比 TIL 疗法 4.1 个月），mOS 为14.8 个月。4）CLDN18.2 ADC 治疗晚期胰腺癌，展现了治疗晚期胰腺癌，展现了 PFS 和和 OS

12、潜力。潜力。2025 ASCO 公布了 Ia/Ib期剂量递增和剂量扩展研究（NCT05458219）扩展队列的最新研究数据：截至2025 年 3 月 14 日，共有 83 例胰腺癌患者接受了至少一次 IBI343 治疗，中位随访时间为 11.1 个月。6mg/kg 剂量组 CLDN18.2 1+2+3+60%的 44 例受试者中，cORR为 22.7%，DCR 为 81.8%，mPFS 为 5.4 个月，mOS 为 9.1 个月。其中既往仅接受过图图1 IBI363 在在 IO 经治非小细胞肺癌数据（经治非小细胞肺癌数据（NCT05460767）58例非小细胞肺腺癌均无已知的EGFR突变，其中

13、30例接受了0.6mg/kg Q2W,1 mg/kg Q2W 或 1.5 mg/kg Q3W IBI363 治疗（56.7%有过往吸烟史），25 例接受了 3 mg/kg Q3W IBI363 治疗（60%过往吸烟史）。3 mg/kg Q3W 剂量组的 cORR 为 24.0%，mPFS 5.6 个月，mOS 尚未成熟（中位随访时间 10.2 个月）。我们认为以上数据也优于现有的免疫疗法。资料来源：2025 ASCO，HTI 0.6/1/1.5 mg/kg(n=30)3 mg/kg(n=25)1/1.5 mg/kg(n=28)3 mg/kg(n=31)确认的ORR,%(95%CI)*13.8(

14、3.9,31.7)24.0(9.4,45.1)25.9(11.1,46.3)36.7(19.9,56.1)DCR,%(95%CI)*62.1(42.3,79.3)76.0(54.9,90.6)66.7(46.0 83.5)90.0(73.5,97.9)中位PFS,月(95%CI)2.7(1.4,5.1)5.6(3.1,9.4)5.5(1.5,8.3)9.3(6.2,11.7)PFS中位随访时间,月(95%CI)21.9(3.1,21.9)10.1(6.1,11.2)16.5(14.1,19.5)11.3(10.1,14.0)中位OS,月(95%CI)17.5(5.6,NC)NC(9.4,NC)

15、15.3(7.6,NC)NC(10.4,NC)12个月OS率,%(95%CI)58.2(38.3,73.8)71.6(45.9,86.6)58.2(37.3,74.3)70.9(49.5,84.5)OS 中位随访时间,月(95%CI)17.7(17.1,20.9)10.2(9.1,11.4)17.3(15.3,20.2)11.3(10.3,11.6)EGFR 野生型肺腺癌野生型肺腺癌鳞状非小细胞肺癌鳞状非小细胞肺癌yXiXpWiW8ViYrQpNmPmObR9R6MoMnNnPrMjMqQqOjMmNpP6MrQrRxNpPrMMYqMqP 9 Jun 2025 3 Table_header1

16、 信达生物(1801 HK)维持优于大市维持优于大市 一线治疗受试者（N=17）的 mPFS 为 5.4 个月，mOS 长达 12.1 个月；既往仅接受过两线治疗受试者（N=18）的 mPFS 为 5.3 个月，mOS 为 9.1 个月。安全性方面，总体耐受性良好，消化道毒性低，未出现新的安全信号。TEAE 事件发生率 98.8%。考虑到目前针对晚期胰腺癌的 12L 治疗方案仍以化疗为主，其中 2L 治疗的临床选择尤为有限，化疗响应率仅为 6-16%，mPFS 约 25 个月，mOS 大约 69 个月，我们认为 IBI343 有望为胰腺癌末线患者提供新的治疗方案。盈利预测及估值建议盈利预测及估

17、值建议 结合公司 IBI363 数据优异，分子成药性提高，考虑到海外肺鳞癌、结直肠癌药物市场空间较大，我们调整盈利预测及估值模型。我们预计 2025-27 年总收入为 118.6/143.4/181.7 亿元（前值：118.6/143.4/180.9），同比+26/+21/+27%。2025 年扭亏为盈，实现净利润 3.8 亿元（前值：不变）。我们采用 DCF 模型对公司进行估值，采用 FY26-37 现金流进行测算，基于 WACC 9.8%（不变），永续增长率 3.5%（不变），假设汇率 RMB:HKD=1:1.14，调整目标价至 90.1 HKD/股（前值：62.5 HKD/股），维持“优

18、于大市”评级。风险风险 新药研发风险，新药审批风险，新药商业化不及预期风险。9 Jun 2025 4 Table_header2 信达生物(1801 HK)维持优于大市维持优于大市 Table 1 DCF 估值模型估值模型 资料来源：公司财报，HTI RMB mFY24AFY25EFY26EFY27EFY28EFY29EFY30EFY31EFY32EFY33EFY34EFY35EFY36EFY37E20242025202620272028202920302031203220332034203520362037Forecast Year1234567888888Time Factor0.00.6

19、1.62.63.64.65.66.67.68.69.610.611.612.6(fraction of year to next FY end)Sales942211863143421817221406248532787830302325243413635517365243748538416.Growth51.8%25.9%20.9%26.7%17.8%16.1%12.2%8.7%7.3%5.0%4.0%2.8%2.6%2.5%Gross Profit79129929121461599118837218712453326666286213003931255321413298733806.GP

20、Margin84.0%83.7%84.7%88.0%88.0%88.0%88.0%88.0%88.0%88.0%88.0%88.0%88.0%88.0%SG&A-8668-10043-11714-14481-16297-17074-18095-19155-20185-20811-21270-21855-22412-22952 SG&A Margin92.0%84.7%81.7%79.7%76.1%68.7%64.9%63.2%62.1%61.0%59.9%59.8%59.8%59.7%Depreciation&Amortisation581488691648627623634658689726

21、765805844881EBIT-1225191066214438236732902711113130361403514998153091560615894Add:Amortisation00000000000000EBITA-1225191066214438236732902711113130361403514998153091560615894 Margin-1.3%4.4%7.4%11.8%17.9%27.1%32.4%36.7%40.1%41.1%42.2%41.9%41.6%41.4%GrowthAdd:Depreciation5814886916486276236346586897

22、26765805844881EBITDA4581,0081,7572,7914,4507,3549,66211,77113,72414,76115,76316,11416,45016,775 Margin4.9%8.5%12.3%15.4%20.8%29.6%34.7%38.8%42.2%43.2%44.4%44.1%43.9%43.7%Less:Tax116-16-68-150-311-563-1,000-1,344-1,657-1,945-2,095-2,240-2,286-2,331Less:Minority Interests-Less:Increase of Working Capi

23、tal3,047-226-113226226453453453453453453453453453Less:Capex-283-356-430-545-642-746-836-909-976-1,024-1,066-1,096-1,125-1,152.Capex:Depreciation0.5x0.7x0.6x0.8x1.0 x1.2x1.3x1.4x1.4x1.4x1.4x1.4x1.3x1.3xLess:Acquisitions0.00.00.00.00.00.00.00.00.00.00.00.00.00.0Free Cash Flow3,3394091,1462,3233,7236,4

24、988,2799,97111,54512,24413,05513,23213,49213,745.FCF Growth-285.6%-87.7%179.9%102.7%60.3%74.5%27.4%20.4%15.8%6.1%6.6%1.4%2.0%1.9%PV of FCF3,3393899901,8282,6704,2444,9245,4015,6965,5025,3434,9324,5814,250Bull CaseWACCDCF ValuationRisk Free Rate3.0%Sum of PV of FCF50,363Market Risk Premium9.5%PV of T

25、erminal Value69,883Equity Beta0.88 Enterprise Value120,246Cost of Equity 11.4%Add:Net Cash FY247,508Cost of Debt(Pre-tax)6.0%Equity Value(RMB mn)127,754Cost of Debt(After tax)5.1%Target Debt weight25.0%Equity Value(USD mn)16,484$Target Equity weight75.0%Equity Value(HKD mn)140,529Tax Rate15.0%FX:1.1

26、0 Diluted weighted shares outstanding 1,560 WACC9.8%Terminal Growth3.5%Value per Share,HKD 90.1HK$9 Jun 2025 5 Table_header2 信达生物(1801 HK)维持优于大市维持优于大市 Table 2 财务模型以及盈利预测财务模型以及盈利预测 资料来源：公司财报，HTI Key financialsDec-24EDec-25EDec-26EDec-27ERevenue(Rmbm)9422118631434218172Operating Profit/Loss(RMBm)-756-

27、1144321,510Pre-tax profit/Loss(RMBm)-1904529982,076Net income to ord equity(RMBm)(206)384 849 1,765 Revenue growth52%26%21%27%Net profit growthn.a.n.a.121.0%107.9%Adjusted net income to ordequity(Rmbm)(206)384 849 1,765 ROE-1.6%2.8%5.9%10.9%Balance Sheet(Rmbm)Dec-24EDec-25EDec-26EDec-27ETotal cash a

28、nd equivalents7,508 7,988 9,173 11,456 Inventories822.2 588.3 66.0 65.6 Account and other receivables376 786 1,487 413 Trade receivables1,184 1,923 2,325 2,945 Other current assets383 383 383 383 Total current assets10,273 11,667 13,434 15,263 Property,plant and equipment5,280 5,147 4,886 4,784 Othe

29、r non-current assets6,050 6,050 6,050 6,050 Total non-current assets11,330 11,197 10,936 10,834 Total assets21,603 22,864 24,370 26,097 Contract liabilities256 256 256 256 Trade and other payable358 634 720 715 Bank borrowing405 405 405 405 Other current liabilities3,350 4,241 4,812 4,779 Total curr

30、ent liabilities4,369 5,536 6,194 6,156 Bank borrowing2,412 2,412 2,412 2,412 Contract liabilities568 568 568 568 Other liabilities1,136 846 846 846 Total non-current liabilities4,116 3,826 3,826 3,826 Total liabilities8,485 9,362 10,020 9,982 Shareholders equity13,118 13,502 14,350 16,115 Minority i

31、nterests-Total equity13,118 13,502 14,350 16,115 Total liabilities&shareholdersequity21,603 22,864 24,370 26,097 Cash flow(Rmbm)Dec-24EDec-25EDec-26EDec-27EOperating profit(756)(114)432 1,510 Deprecation and amortisation581 488 691 648 Changes in working capital(3,047)226 113 (226)Other operating ca

32、sh flow6,901 302 447 965 Cash generated from operations3,679 903 1,684 2,896 Capex(283)(356)(430)(545)Other investing cash flow-Net cash flow from investingactivities(283)(356)(430)(545)Change in borrowings(704)-Proceeds from changes incapital-Other financing cash flow(68)(68)(68)(68)Net cash flow f

33、rom financingactivities(772)(68)(68)(68)Cash at beginning of period7,508 7,988 9,173 11,456 Net change in cash2,624 480 1,186 2,283 Forex effects-Implied cash at end of period7,988 9,173 11,456 15,057 Free cash flow3,396 547 1,253 2,351 Profit&Loss(Rmbm)Dec-24EDec-25EDec-26EDec-27ETotal turnover9,42

34、2 11,863 14,342 18,172 Cost of sales1,510 1,935 2,196 2,181 Gross profit7,912 9,929 12,146 15,991 Total operating costs8,668 10,043 11,714 14,481 Operating profit(756)(114)432 1,510 Operating EBITDA648 1,197 1,947 2,981 Depreciation and amortisation581 488 691 648 Operating EBIT(122)519 1,066 2,144

35、Interest income(expense)190 190 190 190 Share of loss from anassociate/JV-Pre-tax profit(190)452 998 2,076 Taxation16 68 150 311 Net Income(206)384 849 1,765 Minorities-Net Income to ord equity(206)384 849 1,765 One-off expense-Normalized net income(206)384 849 1,765 xPer Share DataDec-24EDec-25EDec

36、-26EDec-27EEPS(Rmb)(0.13)0.24 0.52 1.08 Revenue per share(Rmb)5.79 7.29 8.81 11.17 Operating EBITDA per share(Rmb)0.28 0.62 1.08 1.71 BVPS(Rmb)8.06 8.30 8.82 9.90 DPS(Rmb)-Recurrent cash flow per share(Rmb)1.61 0.29 0.73 1.40 Shares in issue(million)1,627 1,627 1,627 1,627 Year end adjusted shares i

37、nissue(million)1,627 1,627 1,627 1,627 xKey RatiosDec-24EDec-25EDec-26EDec-27EGrowthRevenue growth51.8%25.9%20.9%26.7%Operating profit growth56.1%25.5%22.3%31.7%Net profit growth-80.0%-286.4%121.0%107.9%MarginsGross margin84.0%83.7%84.7%88.0%Operating EBITDA margin4.9%8.5%12.3%15.4%Operating margin-

38、8.0%-1.0%3.0%8.3%Pretax profit margin-2.0%3.8%7.0%11.4%Tax rate0.0%15.0%15.0%15.0%Net profit margin-2.2%3.2%5.9%9.7%Key RatiosROE-1.6%2.8%5.9%10.9%ROA-1.0%1.7%3.5%6.8%Capex/revenue-3.0%-3.0%-3.0%-3.0%Current ratio(x)2.42.12.22.5Creditor days120120120120Debtor days59595959Inventory days111111111Sales

39、/avg assets0.81.11.11.3Credit analysisDebt/EBITDA(x)7.73.21.91.2Debt/equity28%27%25%23%Net debt to equity-16%-13%-16%-28%9 Jun 2025 6 Table_header2 信达生物(1801 HK)维持优于大市维持优于大市 APPENDIX 1 Summary Innovent Biologics Showcases Strong Oncology Innovation Capabilities with Multiple Studies Selected for Ora

40、l Presentation at ASCO Innovent Biologics demonstrated its robust oncology R&D strength at the 2025 American Society of Clinical Oncology(ASCO)Annual Meeting,presenting a series of clinical data from its innovative oncology pipeline.A total of eight studies were selected for oral presentation,accoun

41、ting for approximately 2%of all oral presentations at the conference.These include key research findings on IBI363(PD-1/IL-2-bias)and IBI343(CLDN18.2 ADC).Of particular interest,the IBI363-related presentations covered efficacy and safety data in patients with advanced acral and mucosal melanoma,adv

42、anced colorectal cancer,and advanced non-small cell lung cancer(NSCLC)who had previously received immunotherapy.The Phase I dose-expansion study of IBI343 focused on Claudin18.2 expression and clinical activity in pancreatic ductal adenocarcinoma(PDAC).We think the continued strong data from IBI363

43、in IO-pretreated non-small cell lung cancer(NSCLC)and colorectal cancer(CRC)further validates its potential to become a backbone therapy for the next generation of immuno-oncology(IO)treatments.At the 2025 ASCO Annual Meeting,Innovent presented encouraging Phase I/II data for IBI363 across three cha

44、llenging tumor types characterized by IO resistance and immune-cold profilesNSCLC,CRC,and melanomaall selected as oral presentations.The data demonstrated robust tumor responses and long-term survival benefits,underscoring IBI363s broad clinical potential across indications.1)IBI363 monotherapy show

45、s stronger-than-expected mPFS in IO-resistant advanced NSCLC:Updated results were shared for IBI363 monotherapy in advanced NSCLC patients(Study NCT05460767).As of the data cutoff on April 7,2025,a total of 136 NSCLC patients had received IBI363 monotherapy(ranging from 2 g/kg QW to 4 mg/kg Q3W),inc

46、luding 67 patients with squamous NSCLC and 58 patients with EGFR wild-type adenocarcinoma.Among the 67 squamous NSCLC patients(all with no known EGFR mutations),28 received IBI363 at 1 mg/kg Q2W or 1.5 mg/kg Q3W,and 31 received 3 mg/kg Q3W.In these two groups,the proportion of patients with 2 prior

47、lines of systemic therapy was 64.3%vs.67.7%,prior antiPD-1/PD-L1 exposure was 100%vs.96.8%,and the proportion with PD-L1 TPS 1%was 35.7%vs.41.9%,respectively.Compared with the 1/1.5 mg/kg dosing group,the 3 mg/kg Q3W cohort demonstrated a more pronounced confirmed objective response rate(cORR):cORR:

48、36.7%，Disease Control Rate(DCR):90%，Median Progression-Free Survival(mPFS):9.3 months.This mPFS is comparable to the median overall survival(mOS)of 79 months typically observed with combination regimens such as PD-L1 plus CTLA-4 inhibitors,highlighting the strong potential of IBI363 monotherapy.We b

49、elieve that as overall survival(OS)data matures,it will likely show significant extension in patient survival.The safety profile was generally manageable.Grade 3 treatment-related adverse events(TRAEs)occurred in 43.9%of patients.The most common Grade 3 TRAEs were arthralgia and rash.7.0%of patients

50、 experienced TRAEs leading to permanent treatment discontinuation.There were no treatment-related deaths(0%).2)IBI363 Monotherapy Shows 6-Month OS Extension in Cold Tumor 3L+Colorectal Cancer:In patients with MSS-type colorectal cancer who had failed at least third-line therapy,IBI363 monotherapy de

51、monstrated a median OS(mOS)of 16.1 monthsapproximately six months longer than the 910 months typically reported for current therapies.Among the 63 patients in this cohort(63.2%had received 4 lines of prior therapy;86.8%were MSS),the confirmed ORR was 12.7%,and median duration of response(mDoR)was 7.

52、5 months.Notably,both patients with liver metastasis(mOS:14.4 months)and those without(mOS:17 months)showed significant OS benefit,suggesting a strong tail effect of immunotherapy in cold tumors,potentially reversing the current lack of efficacy of IO agents in this setting.9 Jun 2025 7 Table_header

53、2 信达生物(1801 HK)维持优于大市维持优于大市 In the combination cohort with bevacizumab,the ORR reached 23.5%.While mDoR and mOS were not yet mature,subgroup analyses revealed encouraging efficacy signals in the 3 mg/kg high-dose subgroup,especially in terms of ORR and PFS,supporting further follow-up to assess long

54、-term survival benefits.3)Strong Efficacy of IBI363 in IO-Refractory Acral and Mucosal Melanoma In two Phase I/II clinical studies(NCT05460767,NCT06081920),as of April 7,2025,31 patients with unresectable locally advanced or metastatic acral or mucosal melanoma were treated with IBI363 at 1 mg/kg Q2

55、W.All patients were IO-refractory,and 64.5%(n=20)had received 2 prior lines of systemic therapy.IBI363 achieved a confirmed ORR of 23.3%,significantly outperforming chemotherapy and other standards of care(ORR 711%).Median PFS was 5.7 months(vs.4.1 months for TIL therapy),and median OS was 14.8 mont

56、hs,demonstrating robust antitumor activity in this historically difficult-to-treat population.4)IBI343(CLDN18.2 ADC)Shows Promising PFS and OS in Advanced Pancreatic Cancer At ASCO 2025,updated results from the dose escalation and expansion cohorts of the ongoing Phase Ia/Ib trial(NCT05458219)were p

57、resented.As of March 14,2025,83 patients with advanced pancreatic cancer had received at least one dose of IBI343,with a median follow-up of 11.1 months.Among 44 patients with high CLDN18.2 expression(1+/2+/3+60%)treated at 6 mg/kg,the confirmed ORR was 22.7%,DCR was 81.8%,mPFS was 5.4 months,and mO

58、S reached 9.1 months.Notably,in patients who had only received one prior line of therapy(n=17),mOS reached 12.1 months,while those with two prior lines(n=18)had a comparable mOS of 9.1 months.Safety was generally manageable,with low incidence of GI-related toxicity and no new safety signals observed

59、.The treatment-emergent adverse event(TEAE)rate was 98.8%.Given the current lack of effective therapies for advanced pancreatic cancerespecially in the second-line setting,where chemotherapy response rates range from 616%,mPFS is 25 months,and mOS is 69 monthswe believe IBI343 offers a potentially v

60、aluable new option for late-line pancreatic cancer patients.Earnings Forecast and Valuation Recommendation Given the strong data from IBI36,along with the large market potential for lung squamous cell carcinoma and colorectal cancer treatments overseas,we have updated our earnings forecast and valua

61、tion model.We estimate total revenue for 20252027 to be RMB 11.86/14.34/18.17 billion(previous:RMB 11.86/14.34/18.09 billion),representing year-on-year growth of+26%/+21%/+27%.The company is expected to turn profitable in 2025,with a projected net profit of RMB 380 million(previous forecast:unchange

62、d).We apply a DCF model for valuation,using FY2637 cash flows.Based on a WACC of 9.8%(unchanged)and a terminal growth rate of 3.5%(unchanged),and assuming an exchange rate of RMB:HKD=1:1.14,we raise our target price to HKD 90.1 per share(previous:HKD 62.5),and maintain an“Outperform”rating.Risks Ris

63、ks include new drug R&D risk,regulatory approval risk,and commercialization underperformance risk.8 Table_ESGcomments APPENDIX 2 ESG Comments Environmental:the overall performance of company on environment is good Social:the overall performance of company on society is good Governance:the overall pe

64、rformance of company on government is good 9 Table_APPENDIX Table_disclaimer 附录附录APPENDIX 重要信息披露重要信息披露 本研究报告由海通国际分销，海通国际是由海通国际研究有限公司(HTIRL)，Haitong Securities India Private Limited(HSIPL)，Haitong International Japan K.K.(HTIJKK)和海通国际证券有限公司(HTISCL)的证券研究团队所组成的全球品牌，海通国际证券集团(HTISG)各成员分别在其许可的司法管辖区内从事证券活动

65、。IMPORTANT DISCLOSURES This research report is distributed by Haitong International,a global brand name for the equity research teams of Haitong International Research Limited(“HTIRL”),Haitong Securities India Private Limited(“HSIPL”),Haitong International Japan K.K.(“HTIJKK”),Haitong International

66、Securities Company Limited(“HTISCL”),and any other members within the Haitong International Securities Group of Companies(“HTISG”),each authorized to engage in securities activities in its respective jurisdiction.HTIRL分析师认证分析师认证Analyst Certification:我，孟科含，在此保证（i）本研究报告中的意见准确反映了我们对本研究中提及的任何或所有目标公司或上市公

67、司的个人观点，并且（ii）我的报酬中没有任何部分与本研究报告中表达的具体建议或观点直接或间接相关；及就此报告中所讨论目标公司的证券，我们（包括我们的家属）在其中均不持有任何财务利益。我和我的家属（我已经告知他们）将不会在本研究报告发布后的3个工作日内交易此研究报告所讨论目标公司的证券。I,Kehan Meng,certify that(i)the views expressed in this research report accurately reflect my personal views about any or all of the subject companies or iss

68、uers referred to in this research and(ii)no part of my compensation was,is or will be directly or indirectly related to the specific recommendations or views expressed in this research report;and that I(including members of my household)have no financial interest in the security or securities of the

69、 subject companies discussed.I and my household,whom I have already notified of this,will not deal in or trade any securities in respect of the issuer that I review within 3 business days after the research report is published.我，宁嘉骏，在此保证（i）本研究报告中的意见准确反映了我们对本研究中提及的任何或所有目标公司或上市公司的个人观点，并且（ii）我的报酬中没有任何部

70、分与本研究报告中表达的具体建议或观点直接或间接相关；及就此报告中所讨论目标公司的证券，我们（包括我们的家属）在其中均不持有任何财务利益。我和我的家属（我已经告知他们）将不会在本研究报告发布后的3个工作日内交易此研究报告所讨论目标公司的证券。I,Jiajun Ning,certify that(i)the views expressed in this research report accurately reflect my personal views about any or all of the subject companies or issuers referred to in th

71、is research and(ii)no part of my compensation was,is or will be directly or indirectly related to the specific recommendations or views expressed in this research report;and that I(including members of my household)have no financial interest in the security or securities of the subject companies dis

72、cussed.I and my household,whom I have already notified of this,will not deal in or trade any securities in respect of the issuer that I review within 3 business days after the research report is published.利益冲突披露利益冲突披露Conflict of Interest Disclosures 海通国际及其某些关联公司可从事投资银行业务和/或对本研究中的特定股票或公司进行做市或持有自营头寸。就

73、本研究报告而言，以下是有关该等关系的披露事项（以下披露不能保证及时无遗漏，如需了解及时全面信息，请发邮件至ERD-D）HTI and some of its affiliates may engage in investment banking and/or serve as a market maker or hold proprietary trading positions of certain stocks or companies in this research report.As far as this research report is concerned,the follo

74、wing are the disclosure matters related to such relationship(As the following disclosure does not ensure timeliness and completeness,please send an email to ERD-D if timely and comprehensive information is needed).No Disclosure 评级定义评级定义（从（从2020年年7月月1日开始执行）日开始执行）：海通国际（以下简称“HTI”）采用相对评级系统来为投资者推荐我们覆盖的公司

75、：优于大市、中性或弱于大市。投资者应仔细阅读HTI的评级定义。并且HTI发布分析师观点的完整信息，投资者应仔细阅读全文而非仅看评级。在任何情况下，分析师的评级和研究都不能作为投资建议。投资者的买卖股票的决策应基于各自情况（比如投资者的现有持仓）以及其他因素。分析师股票评级分析师股票评级 优于大市优于大市，未来12-18个月内预期相对基准指数涨幅在10%以上，基准定义如下 中性中性，未来12-18个月内预期相对基准指数变化不大，基准定义如下。根据FINRA/NYSE的评级分布规则，我们会将中性评级划入持有这一类别。弱于大市弱于大市，未来12-18个月内预期相对基准指数跌幅在10%以上，基准定义如

76、下 各地股票基准指数：日本 TOPIX,韩国 KOSPI,台湾 TAIEX,印度 Nifty100,美国 SP500;其他所有中国概念股 MSCI China.Ratings Definitions(from 1 Jul 2020):Haitong International uses a relative rating system using Outperform,Neutral,or Underperform for recommending the stocks we cover to investors.Investors should carefully read the defi

77、nitions of all ratings used in Haitong International Research.In addition,since Haitong International Research contains more complete information concerning the analysts views,investors should carefully read Haitong International Research,in its entirety,and not infer the contents from the rating al

78、one.In any case,ratings(or research)should not be used or relied upon as investment advice.An investors decision to buy or sell a stock should depend on individual circumstances(such as the investors existing holdings)and other considerations.Analyst Stock Ratings Outperform:The stocks total return

79、over the next 12-18 months is expected to exceed the return of its relevant broad market benchmark,as indicated below.Neutral:The stocks total return over the next 12-18 months is expected to be in line with the return of its relevant broad market benchmark,as indicated below.For purposes only of FI

80、NRA/NYSE ratings distribution rules,our Neutral rating falls into a hold rating category.Underperform:The stocks total return over the next 12-18 months is expected to be below the return of its relevant broad market benchmark,as indicated below.Benchmarks for each stocks listed region are as follow

81、s:Japan TOPIX,Korea KOSPI,Taiwan TAIEX,India Nifty100,US SP500;for all other China-concept stocks MSCI China.10 截至截至2025年年3月月31日海通国际股票研究评级分布日海通国际股票研究评级分布截至截至2024年年12月月31日海通国际股票研究评级分布日海通国际股票研究评级分布 优于大市优于大市 中性中性 弱于大市弱于大市 优于大市优于大市 中性中性 弱于大市弱于大市(持有)(持有)海通国际股票研究覆盖率 92.2%7.5%0.3%91.9%7.6%0.4%投资银行客户*3.3%3.

82、5%0.0%2.1%2.2%0.0%*在每个评级类别里投资银行客户所占的百分比。上述分布中的买入，中性和卖出分别对应我们当前优于大市，中性和落后大市评级。只有根据FINRA/NYSE的评级分布规则，我们才将中性评级划入持有这一类别。请注意在上表中不包含非评级的股票。此前的评级系统定义（直至此前的评级系统定义（直至2020年年6月月30日）：日）：买入，未来12-18个月内预期相对基准指数涨幅在10%以上，基准定义如下中性，未来12-18个月内预期相对基准指数变化不大，基准定义如下。根据FINRA/NYSE的评级分布规则，我们会将中性评级划入持有这一类别。卖出，未来12-18个月内预期相对基准指

83、数跌幅在10%以上，基准定义如下各地股票基准指数：日本 TOPIX,韩国 KOSPI,台湾 TAIEX,印度 Nifty100;其他所有中国概念股 MSCI China.Haitong International Equity Research Ratings Distribution,Haitong International Equity Research Ratings Distribution,as of March 31,2025 as of December 31,2024 Outperform Neutral Underperform Outperform Neutral Und

84、erperform(hold)(hold)HTI Equity Research Coverage 92.2%7.5%0.3%91.9%7.6%0.4%IB clients*3.3%3.5%0.0%2.1%2.2%0.0%*Percentage of investment banking clients in each rating category.BUY,Neutral,and SELL in the above distribution correspond to our current ratings of Outperform,Neutral,and Underperform.For

85、 purposes only of FINRA/NYSE ratings distribution rules,our Neutral rating falls into a hold rating category.Please note that stocks with an NR designation are not included in the table above.Previous rating system definitions(until 30 Jun 2020):BUY:The stocks total return over the next 12-18 months

86、 is expected to exceed the return of its relevant broad market benchmark,as indicated below.NEUTRAL:The stocks total return over the next 12-18 months is expected to be in line with the return of its relevant broad market benchmark,as indicated below.For purposes only of FINRA/NYSE ratings distribut

87、ion rules,our Neutral rating falls into a hold rating category.SELL:The stocks total return over the next 12-18 months is expected to be below the return of its relevant broad market benchmark,as indicated below.Benchmarks for each stocks listed region are as follows:Japan TOPIX,Korea KOSPI,Taiwan T

88、AIEX,India Nifty100;for all other China-concept stocks MSCI China.海通国际非评级研究：海通国际非评级研究：海通国际发布计量、筛选或短篇报告，并在报告中根据估值和其他指标对股票进行排名，或者基于可能的估值倍数提出建议价格。这种排名或建议价格并非为了进行股票评级、提出目标价格或进行基本面估值，而仅供参考使用。Haitong International Non-Rated Research:Haitong International publishes quantitative,screening or short reports w

89、hich may rank stocks according to valuation and other metrics or may suggest prices based on possible valuation multiples.Such rankings or suggested prices do not purport to be stock ratings or target prices or fundamental values and are for information only.海通国际海通国际A股覆盖股覆盖：海通国际可能会就沪港通及深港通的中国A股进行覆盖及

90、评级。国泰海通证券（601211.CH），海通国际于上海的母公司，也会于中国发布中国A股的研究报告。但是，海通国际使用与国泰海通证券不同的评级系统，所以海通国际与国泰海通证券的中国A股评级可能有所不同。Haitong International Coverage of A-Shares:Haitong International may cover and rate A-Shares that are subject to the Hong Kong Stock Connect scheme with Shanghai and Shenzhen.GUOTAI HAITONG SECURITIE

91、S(601211 CH),the ultimate parent company of HTISG based in Shanghai,covers and publishes research on these same A-Shares for distribution in mainland China.However,the rating system employed by GTHS differs from that used by HTI and as a result there may be a difference in the HTI and GTHS ratings f

92、or the same A-share stocks.海通国际海通国际优质优质100 A股股（Q100）指数指数：海通国际Q100指数是一个包括100支由国泰海通证券覆盖的优质中国A股的计量产品。这些股票是通过基于质量的筛选过程，并结合对国泰海通证券 A股团队自下而上的研究。海通国际每季对Q100指数成分作出复审。Haitong International Quality 100 A-share(Q100)Index:HTIs Q100 Index is a quant product that consists of 100 of the highest-quality A-shares u

93、nder coverage at GTHS in Shanghai.These stocks are carefully selected through a quality-based screening process in combination with a review of the GTHS A-share teams bottom-up research.The Q100 constituent companies are reviewed quarterly.盟浪义利（盟浪义利（FIN-ESG）数据通免责声明条款：）数据通免责声明条款：在使用盟浪义利（FIN-ESG）数据之前，

94、请务必仔细阅读本条款并同意本声明：第一条 义利（FIN-ESG）数据系由盟浪可持续数字科技有限责任公司（以下简称“本公司”）基于合法取得的公开信息评估而成，本公司对信息的准确性及完整性不作任何保证。对公司的评估结果仅供参考，并不构成对任何个人或机构投资建议，也不能作为任何个人或机构购买、出售或持有相关金融产品的依据。本公司不对任何个人或机构投资者因使用本数据表述的评估结果造成的任何直接或间接损失负责。第二条 盟浪并不因收到此评估数据而将收件人视为客户，收件人使用此数据时应根据自身实际情况作出自我独立判断。本数据所载内容反映的是盟浪在最初发布本数据日期当日的判断，盟浪有权在不发出通知的情况下更新

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